Roflumilast foam 0.3% is now U.S. Food and Drug Administration–approved as a once-daily, steroid-free topical treatment specifically formulated to treat plaque psoriasis across the scalp and body, including hair-bearing areas.

The U.S. Food and Drug Administration (FDA) has approved the topical treatment in patients aged 12 years and older. Developed by Arcutis Biotherapeutics, roflumilast foam is a once-daily, steroid-free topical therapy designed for use in hair-bearing areas where conventional creams and ointments may be difficult to apply.

Plaque psoriasis affects approximately 9 million patients in the United States, with scalp involvement reported in more than half of cases. The approval is based on results from a phase II trial and the pivotal phase III ARRECTOR study, both randomized, double-blind, vehicle-controlled trials. In the ARRECTOR trial, 66.4% of patients treated with roflumilast foam achieved Scalp-Investigator Global Assessment Success at week 8 compared with 27.8% of those receiving vehicle. Body-Investigator Global Assessment Success was achieved by 45.5% of patients in the treatment group vs 20.1% of those in the vehicle group. Findings from Trial 204 were consistent with these outcomes.

Roflumilast foam also produced clinically meaningful improvements in itch. In the ARRECTOR trial, 65.3% of patients achieved at least a 4-point reduction in scalp itch on the Scalp Itch–Numeric Rating Scale at week 8 compared with 30.3% using vehicle. Reductions in itch intensity were observed as early as 24 hours following the initial application. Improvements in body itch were also noted, with 63.1% of patients achieving at least a 4-point reduction on the Worst Itch–Numeric Rating Scale compared with 30.1% of patients treated with vehicle.

The safety profile of roflumilast foam was favorable, with low rates of treatment-emergent adverse events (TEAE), most of which were mild or moderate in severity. The most common TEAEs included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

Roflumilast foam complements the cream formulation and provides physicians with an additional option for treating plaque psoriasis across body regions, including difficult-to-treat sites. Both formulations are approved for long-term use without duration limits. Arcutis Biotherapeutics supports access through the ZORYVE Direct and Arcutis Cares patient assistance programs.

Source: Arcutis Biotherapeutics